A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7373 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-16

Study Completion Date

2021-02-03

Brief Summary

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Recent studies have shown that some individuals may be asymptomatic but continue to shed the COVID-19 virus. These individuals may represent a population that can unknowingly transmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community or from possibly infected patients. It is important to gather data with respect to this to further understand the prevalence of asymptomatic carriage in individuals who work in research facilities, offices and clinical areas of hospitals and research facilities/institutes since this has important implications for infection control, as well as staff and patient safety. The purpose of this study is to test whether a proportion of these individuals may be asymptomatic shedders of the COVID-19 virus.

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Detailed Description

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Healthcare workers of participating institutions who agree to be participants will:

* Fill out some information about participants into a database portal system. Participants will have the ability to check their COVID-19 test results via the portal.
* Have nasopharyngeal (NP) swabs done for COVID-19 testing. This can be done about once a week for up to 8 weeks (about 1-8 swabs total).
* Provide optional blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
* Fill out questionnaires about participant exposures and travel history, occupation category, any symptoms in the past 21 days, whether they have provided any face-to-face care of a known COVID-19 positive patients in past 14 days or if participants have any children at home who are less than 12 years of age.
* Fill out an optional questionnaire about their mental health
* Be contacted by telephone if participants are tested positive, to determine whether participants have symptoms of COVID-19, and for the results of any follow-up COVID-19 testing that may have been done.

Conditions

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Healthcare Worker Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1 (A and B)

Cohort 1A included health care workers. Cohort 1B includes individuals that work within a healthcare, research or clinical organization.

Nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swab for COVID-19

Questionnaire collection (CITF)

Intervention Type OTHER

Fill out questionnaires regarding exposures and travel history, occupation category, any symptoms in the past 21 days, any face-to-face care of a known COVID-19 positive patients in past 14 days or any children at home who are less than 12 years of age.

Optional blood collection

Intervention Type OTHER

Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.

Optional questionnaire completion (mental health)

Intervention Type OTHER

Fill out an optional mental health questionnaire.

Optional saliva sample (for validation)

Intervention Type DIAGNOSTIC_TEST

Provide saliva sample anonymously.

Nasal Swab (rapid antigen test)

Intervention Type DIAGNOSTIC_TEST

Panbio nasal swab rapid antigen test

Cohort 2

Cohort 2 includes Individuals that work within a food production organization.

Nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swab for COVID-19

Questionnaire collection (CITF)

Intervention Type OTHER

Fill out questionnaires regarding exposures and travel history, occupation category, any symptoms in the past 21 days, any face-to-face care of a known COVID-19 positive patients in past 14 days or any children at home who are less than 12 years of age.

Optional blood collection

Intervention Type OTHER

Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.

Optional questionnaire completion (mental health)

Intervention Type OTHER

Fill out an optional mental health questionnaire.

Optional saliva sample (for validation)

Intervention Type DIAGNOSTIC_TEST

Provide saliva sample anonymously.

Cohort 3

Cohort 3 includes individuals that work within a healthcare, research or clinical organization that will be tested via nasal swab only, with increased frequency of testing.

Nasopharyngeal swab

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swab for COVID-19

Optional blood collection

Intervention Type OTHER

Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.

Optional questionnaire completion (mental health)

Intervention Type OTHER

Fill out an optional mental health questionnaire.

Optional saliva sample (for validation)

Intervention Type DIAGNOSTIC_TEST

Provide saliva sample anonymously.

Nasal Swab (rapid antigen test)

Intervention Type DIAGNOSTIC_TEST

Panbio nasal swab rapid antigen test

Interventions

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Nasopharyngeal swab

Nasopharyngeal swab for COVID-19

Intervention Type DIAGNOSTIC_TEST

Questionnaire collection (CITF)

Fill out questionnaires regarding exposures and travel history, occupation category, any symptoms in the past 21 days, any face-to-face care of a known COVID-19 positive patients in past 14 days or any children at home who are less than 12 years of age.

Intervention Type OTHER

Optional blood collection

Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.

Intervention Type OTHER

Optional questionnaire completion (mental health)

Fill out an optional mental health questionnaire.

Intervention Type OTHER

Optional saliva sample (for validation)

Provide saliva sample anonymously.

Intervention Type DIAGNOSTIC_TEST

Nasal Swab (rapid antigen test)

Panbio nasal swab rapid antigen test

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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COVID-19 Immunity Task Force (CITF)

Eligibility Criteria

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Inclusion Criteria

* Individuals who work within a food production, healthcare, research or clinical organization.
* Asymptomatic as per daily screening.
* No contraindication to performing a NP swab.

Exclusion Criteria

* Any individual with fever, respiratory or flu-like symptoms will not be eligible. Symptom positive individuals who were not picked up at entry screening will be referred to their Occupational Health. Specific symptoms include:

* Fever, chills or headache
* New or worsening cough
* Shortness of breath, difficulty breathing, sore throat or difficulty swallowing
* Runny nose or stuffy nose without another cause (e.g. allergies)
* Nausea/vomiting, diarrhea, stomach pain
* Decrease/loss of taste or smell
* Unexplained fatigue, malaise, muscle aches
* Eye pain or pink eye In addition to those symptoms listed above, individuals should also be screened for symptoms as per their institutional requirements.
* Enrolled in a COVID-related interventional study (eg. Behavioural or drug study).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes